A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxAsia)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Resistant Hypertension; Uncontrolled Hypertension

Treatments: Drug: Placebo; Drug: Baxdrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06344104

D6970C00008

Details and patient eligibility

About

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

Full description

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants must be ≥ 18 years old.

• Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.

• Fulfil at least 1 of the following 2 criteria:

  1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
  2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.

• Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.

• Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.

Exclusion criteria

• Mean seated SBP on AOBPM ≥ 170 mmHg.
• Mean seated DBP on AOBPM ≥ 105 mmHg.
• Serum sodium level (Na+) < 135 mmol/L at Screening.
• Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
• NYHA functional heart failure class IV at Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

2 mg baxdrostat

Experimental group

Description:

2 mg baxdrostat administered orally, once daily (QD)

Treatment:

Drug: Baxdrostat

1 mg baxdrostat

Experimental group

Description:

1 mg baxdrostat administered orally, once daily (QD).

Treatment:

Drug: Baxdrostat

placebo

Placebo Comparator group

Description:

Placebo administered orally, once daily (QD)

Treatment:

Drug: Placebo